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Breast Cancer Invasive / Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel / Hormone Receptor Positive Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 clinical trial registration comparing neoadjuvant pyrotinib combined with chemotherapy against chemotherapy alone in HR-positive, HER2-low early breast cancer. No results have been posted in this registry record; the trial remains active but not recruiting.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer; age from 17 Years; to 70 Years. Intervention: Neoadjuvant pyrotinib combined with chemotherapy. Compared with: Neoadjuvant chemotherapy — Placebo Comparator. n = 160. 1 site: China.
This is a Phase 3 clinical trial registration comparing neoadjuvant pyrotinib combined with chemotherapy against chemotherapy alone in HR-positive, HER2-low early breast cancer. No results have been posted in this registry record; the trial remains active but not recruiting.
No efficacy or safety results have been reported in this registry record.
Once results are available, this trial will evaluate whether adding the tyrosine kinase inhibitor pyrotinib to neoadjuvant chemotherapy improves pathological complete response rates in this population. Clinicians should await published results to assess clinical utility.
This is a Phase 3 trial registration with no reported results; the study is active but not recruiting, so outcomes remain unreported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial will evaluate whether adding the tyrosine kinase inhibitor pyrotinib to neoadjuvant chemotherapy improves pathological complete response rates in this population. Clinicians should await published results to assess clinical utility.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06144944). This is a study registration, not published results. Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 160 participants (ESTIMATED). Conditions: Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer. Interventions: DRUG: Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel; DRUG: Epirubicin or doxorubicin, cyclophosphamide, paclitaxel. Primary outcome measures: Residual Cancer Burden 0/1 rate as assessed by independent central review , Within 4 weeks after surgery. Brief summary: This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.